Objectives: Sudden changes in blood glucose level is mainly due to patient stress, operation related stresses and injection of anesthetics containing epinephrine, which can cause problems for both patient and dentist. Therefore, it is recommended to constantly monitor the blood glucose level and maintain it in its normal range.
Design: This study is prospective randomized clinical trial.Setting and conduct: 33 healthy patients undergoing dental implant surgery select and divide into two groups. Conscious sedation in one group perform by midazolam and in the other group carry out by propofol. Pre-operation stress and blood glucose level measure in 4 different stages including: 1) Before operation, 2) Two minutes after local anesthetic injection, 3) 10 minutes after onset of operation and 4) At the end of operation and then result analyzed.
Participants including major eligibility criteria: all of people in study must have ASA I,II؛ Age between 35-60 years؛ No diabetes disease؛ Not intake Corton؛ Need 2 or 3 implant؛ No contraindication of use of Midazolam and Propofol and if they have Need to bone or sinus surgery؛ Systemic disease؛ Problem during surgery؛ time of surgery over than 1.5 hours omitted from study. Intervention: in this study uses of 2 intro-venous sedative drugs, Midazolam in one groups of patients and propofol in another groups. main outcome measures (variables): patient's blood glucose measure in 4 different times during surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201303144224N20
Registration date:2013-07-24, 1392/05/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-07-24, 1392/05/02
Registrant information
Name
Nasser Kaviani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2858
Email address
kaviani@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research of Isfahan dental school، Dentistry school، Isfahan university of medical science، Hezar Jarib street، Isfahan، Iran.
Expected recruitment start date
2013-04-06, 1392/01/17
Expected recruitment end date
2013-07-26, 1392/05/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compressive evaluation of change of blood glucose during sedation with Midazolam and Propofol in implant surgery
Public title
Compressive of blood glucose between 2 sedative drugs Midazolam and Propofol in implant surgery
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion Criteria: ASA I,II؛ Age between 35-60 years؛ No diabetes disease؛ Not intake Corton؛ Having satisfaction about sedation and blood glucose measurement؛ Need 2 or 3 implant؛ No contraindication of use of Midazolam and Propofol.
Exclusion Criteria: No patient satisfaction؛ Need to bone or sinus surgery؛ Systemic disease؛ Problem during surgery؛ Time of surgery over than 90 minutes.
Age
From 35 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice chancellor for Research of Isfahan university of medical sciences
Street address
Dental school، University of medical sciences، Hezar Jerib st، Isfahan
City
Isfahan
Postal code
Approval date
2012-09-24, 1391/07/03
Ethics committee reference number
388428
Health conditions studied
1
Description of health condition studied
Blood glucose
ICD-10 code
R73
ICD-10 code description
Elevated blood glucose level
Primary outcomes
1
Description
blood glucose
Timepoint
in 4 different times during surgery
Method of measurement
Acuu chek system
Secondary outcomes
1
Description
Anxiety
Timepoint
one time before surgery
Method of measurement
according to DAS scale
Intervention groups
1
Description
Admistartion1 drug regime to 1 patients groups: One milligram midazolam (Tehran Chemie Pharmaceutical co, Iran) inject and when needed, it repeat every 2 minutes until the patient entered the sedated condition.
Category
Treatment - Drugs
2
Description
Admistartion1 drug regime to 1 patients groups: 25µg/kg/min propofol (Dongkook pharma Co, Korea) by infusion pomp.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental school of Isfahan university of medical sciences
Full name of responsible person
dr. Mina Shahtoosi
Street address
Surgery center، Dentistry school، Isfahan university of medical science، Hezar Jarib street، Isfahan، Iran.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellor for Research of Isfahan university of medical sciences
Full name of responsible person
Mr Tavangar
Street address
Dentistry school، Hezar Jarib street، Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice chancellor for Research of Isfahan university of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Dental school of Isfahan medical sciences
Full name of responsible person
Mina Shahtoosi
Position
Dental resident
Other areas of specialty/work
Street address
Dentistry school، Hezar Jarib street، Isfahan
City
Isfahan
Postal code
Phone
+98 31 1792 2858
Fax
Email
m.shahtusi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental school of Isfahan university of medical sciences
Full name of responsible person
Mina Shahtoosi
Position
Dental resident
Other areas of specialty/work
Street address
Dentistry school، Hezar Jarib street، Isfahan
City
Isfahan
Postal code
Phone
+98 31 1792 2858
Fax
Email
m.shahtusi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan university of medical sciences
Full name of responsible person
Nasser kaviani
Position
Anesthiologist, Assisstant professor
Other areas of specialty/work
Street address
Dentistry school، Hezar Jarib street، Isfahan
City
Isfahan
Postal code
Phone
+98 31 1792 2858
Fax
Email
kaviani@dnt.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)